NCT01773044

Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Inonu University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain. Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.

Conditions

• Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine

Interventions

Type	Name	Description
DRUG	alkalinized lidocaine	recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
DRUG	Lidocaine	0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),
DRUG	Placebo (for alcalinized lidocaine)

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2013-01-23
• Last updated: 2013-01-23

Locations

1 site across 1 country: Turkey (Türkiye)